CicatrixPhase 1/2NCT00984581
Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects
A Phase 1/2 study testing Avotermin in people with Cicatrix and Wound Healing, run by Renovo at 1 site in United Kingdom.
Trial summary
To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Wound Healing
- What is being tested?
- Avotermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2003to Aug 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically healthy, female subjects aged 18-45 years
- Weight between 40-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-35 kg/m(squared)). Weight(kg)/height (squared)(m)
- Subjects who use appropriate non-pharmaceutical methods of contraception or are not likely to become pregnant for the duration of the trial
Who cannot join
- Subjects who have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied
- Subjects with a personal history of a bleeding disorder
- Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
- Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial
- Subjects with any clinically significant medical condition that would impair wound healing including significant rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled digestive heart failure, active malignancy, immunosuppressive, radiation or chemotherapy within the last three months, a history of radiotherapy to the arm or diabetes mellitus
- Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial
Show all 14Show fewer
- Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination
- Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, HRT, oral contraceptive pill, other pharmaceutical methods of contraception or anticoagulant drugs in the thirty days prior to Day 0
- Subjects who have evidence of drug abuse
- Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against hepatitis B are not excluded per se
- Subjects who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs
- Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high risk group and subjects who at any point have a positive pregnancy test
- Subjects who are pregnant or become pregnant during the trial
- In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-site, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and Anti-scarring Potential of Intradermal Juvista in Female Subjects Aged 18-45 Years
To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.
Read the detailed description
Subjects were to receive two 1cm incisions on the upper, inner aspect of each arm (four wounds per subject).
On Day 0 all subjects received intradermal Juvista at a concentration of 50ng/100ul to one incision site on Arm 1 and 5ng/100ul to one incision site on Arm 2. The other incision sites were injected with placebo. Following injection, 1cm incision wounds were made at each site.
On Day 1 all subjects were re-injected with 100ul/cm intradermal Juvista or placebo to each side of the wound (200ul per incision) at the same concentration as for Day 0 (50 or 5ng/100ul).
At month 6 all incision sites were excised for histological analysis and all excision sites injected with Juvista. Both sites on Arm 1 received 50ng/100ul/linear cm wound margin and both sites on Arm 2 received 5ng/100ul/linear cm wound margin. No excision sites received placebo.
The appearance of excision scars was then assessed after 2, 4 and 6 months of healing i.e at months 8, 10 and 12 of the study.
- Conditions
- Cicatrix, Wound Healing
- Being tested
- Avotermin, Placebo
- Keywords
- Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvoterminDrug
Also called TGFbeta 3, Juvista
Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
AvoterminDrug
Also called TGFbeta 3, Juvista
Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
PlaceboDrug
Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1
| Study group | Role | What they receive |
|---|---|---|
| Intradermal avotermin | Experimental | Not described Receives: Drug: Avotermin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.
Measured: Month 6
Secondary outcomes (2)
To assess systemic exposure following intradermal Juvista before and after minor skin incisions.
Measured: Month 6
To assess the anti-scarring potential of intradermal Juvista in a young female population.
Measured: Month 6-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startApr 2003
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathan Duncan, Principal investigator, RenovoJeremy Bond, Principal investigator, Renovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984581
- Sponsor's protocol ID
- RN1001-319-1006
- Status last verified
- Sep 2009
- First submitted
- 15 Sep 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and Anti-scarring Potential of Intradermal Juvista in Female Subjects Aged 18-45 Years
- ClinicalTrials.gov ID
- NCT00984581
- Acronym / sponsor ID
- RN1001-319-1006
- Conditions
- Cicatrix, Wound Healing
- Keywords
- Cicatrix, Scar, Wound healing, Avotermin, TGF beta 3, Juvista, RN1001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.
Detailed description
Subjects were to receive two 1cm incisions on the upper, inner aspect of each arm (four wounds per subject).
On Day 0 all subjects received intradermal Juvista at a concentration of 50ng/100ul to one incision site on Arm 1 and 5ng/100ul to one incision site on Arm 2. The other incision sites were injected with placebo. Following injection, 1cm incision wounds were made at each site.
On Day 1 all subjects were re-injected with 100ul/cm intradermal Juvista or placebo to each side of the wound (200ul per incision) at the same concentration as for Day 0 (50 or 5ng/100ul).
At month 6 all incision sites were excised for histological analysis and all excision sites injected with Juvista. Both sites on Arm 1 received 50ng/100ul/linear cm wound margin and both sites on Arm 2 received 5ng/100ul/linear cm wound margin. No excision sites received placebo.
The appearance of excision scars was then assessed after 2, 4 and 6 months of healing i.e at months 8, 10 and 12 of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal avotermin | Experimental | Drug: Avotermin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinically healthy, female subjects aged 18-45 years
- Weight between 40-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-35 kg/m(squared)). Weight(kg)/height (squared)(m)
- Subjects who use appropriate non-pharmaceutical methods of contraception or are not likely to become pregnant for the duration of the trial
Key exclusion criteria (14 listed)
- Subjects who have history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied
- Subjects with a personal history of a bleeding disorder
- Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
- Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial
- Subjects with any clinically significant medical condition that would impair wound healing including significant rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled digestive heart failure, active malignancy, immunosuppressive, radiation or chemotherapy within the last three months, a history of radiotherapy to the arm or diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvoterminAlso: TGFbeta 3, JuvistaIntradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6 | Drug | Intradermal avotermin |
| AvoterminAlso: TGFbeta 3, JuvistaIntradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6 | Drug | Intradermal avotermin |
| PlaceboIntradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1 | Drug | Placebo |
Primary outcome
To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group.
Time frame: Month 6
2 secondary outcomes
To assess systemic exposure following intradermal Juvista before and after minor skin incisions.
Time frame: Month 6
To assess the anti-scarring potential of intradermal Juvista in a young female population.
Time frame: Month 6-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Duncan principal investigator
Renovo
Jeremy Bond principal investigator
Renovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Avotermin in people with Cicatrix and Wound Healing, run by Renovo at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group. (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009.